Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage

Status: Recruiting
Location: See location...
Study Type: Observational [Patient Registry]
SUMMARY

The vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice. ERCP has a failure rate ranging from 12 - 25 percent. Percutaneous transhepatic biliary drainage (PTBD) is the alternative conventional way to drain the biliary tree after ERCP failure, which is related with substantial morbidity (62%) and mortality (17%). Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is a novel promising drainage modality with reported excellent outcomes in terms of clinical success and complications. The implementation of EUS-BD besides ERCP and PTBD into Dutch daily clinical practice raises many questions related to performance, costs, QoL, training, implementation and overall oncological treatment success. This structured learning/proctoring program with an additional national registry provides insights into EUS-BD and how to implement EUS-BD in the Dutch standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 18 years and older

• Distal malignant CBD obstruction (from ampulla to 1cm distal to the hilum)

• Indication for biliary drainage after failed ERCP-guided biliary drainage

Locations
Other Locations
Netherlands
Radboudumc
Recruiting
Nijmegen
Contact Information
Primary
Mike de Jong, MD
mike.dejong@radboudumc.nl
0031883207054
Backup
Erwin van Geenen, MD, PhD
erwin.vangeenen@radboudumc.nl
0031243619190
Time Frame
Start Date: August 1, 2022
Estimated Completion Date: August 1, 2024
Participants
Target number of participants: 58
Treatments
PTBD after failed ERCP
Patients with a distal malignant obstruction undergoing placement of a percutaneous transhepatic biliary drain after failed ERCP.
EUS-BD after failed ERCP
Patients with a distal malignant obstruction undergoing EUS-guided biliary drainage after failed ERCP.
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov